Nomides, 45 mg capsules 10 pcs

Nomides is an antiviral drug that contains oseltamiviracarboxylate, which inhibits influenza A and B viruses. As a result, it suppresses: the release of newly formed viral particles from infected cells, their penetration into the respiratory epithelial cells and further spread of the virus in the body.

Nomides is effective in the prevention and treatment of influenza in adults and children over 1 year old. When initiated no later than 40 hours after the onset of symptoms, Nomides shortens considerably the clinical manifestations of influenza infection, reduces their severity and decreases the frequency of flu complications requiring antibiotics (bronchitis, pneumonia, sinusitis, otitis media) and shortens the time of virus discharge from the body.

After oral administration oseltamivir phosphate is easily absorbed in the gastrointestinal tract and is highly converted to the active metabolite under the action of hepatic esterases. Plasma concentrations of the active metabolite are determined within 30 minutes and reach near maximum levels 2-3 hours after administration. At least 75% of the dose taken orally enters the systemic bloodstream as an active metabolite. Plasma concentrations are proportional to the dose and independent of food intake.

Indications

Active ingredient

Composition

Active ingredient:

Oseltamivir phosphate 59.10 mg, which corresponds to the content of Oseltamivir 45.00 mg.

Excipients:

Silicon dioxide colloid (aerosil) – 6.00 mg/9.00 mg/15.00 mg;

p> copovidone -3.60 mg/5.40 mg/9.00 mg;

pregelatinized starch – 65.60 mg/98.40 mg/164.00 mg;

croscarmellose sodium – 1.840 mg/2.760 mg/4.60 mg;

sodium stearyl fumarate -0.920 mg/1.380 mg/2.30 mg;

talc – 2.640 mg/3.960 mg/6.60 mg.

Composition of hard gelatin capsules:

Capsule body: purified water – 14-15 mg, sodium lauryl sulfate – 0.08 mg, titanium dioxide – 0.97524 mg, brilliant blue dye – 0.2626 mg, gelatin – up to 100 mg;

capsule cap: purified water – 14-15 mg, sodium lauryl sulfate – 0.08 mg, titanium dioxide – 0.97524 mg, diamond blue dye – 0.2626 mg, gelatin – up to 100 mg.

How to take, the dosage

Interaction

Clinically significant drug interactions are unlikely according to pharmacological and pharmacokinetic studies. Oseltamivir phosphate is highly converted to active metabolite under the action of esterases mainly located in the liver. Drug interactions caused by competition for binding to active esterase centers are not widely reported in the literature.

The low degree of binding of oseltamivir and the active metabolite to plasma proteins does not suggest interactions related to displacement of drugs from binding to proteins. In vitro studies show that neither oseltamivir phosphate nor its active metabolite is a preferred substrate for polyfunctional cytochrome P450 oxidases or for glucuronyltransferases.

There is no reason for interaction with oral contraceptives. Cimetidine, a nonspecific inhibitor of cytochrome P450 system isoenzyme and competes in the process of tubular secretion with alkaline and cationic drugs, does not affect plasma concentrations of oseltamivir and its active metabolite.

It is unlikely that there are clinically significant interdrug interactions involving competition for tubular secretion, given the safety margin for most such drugs, the excretion routes for the active metabolite of oseltamivir (glomerular filtration and anionic tubular secretion), and the excretion capacity of each route.

Probenecid results in an AUC increase of the active metabolite of oseltamivir by approximately 2-fold (due to reduced active renal tubular secretion). However, no dose adjustment is required when concomitant use with probenecid, given the safety margin of the active metabolite.

Concomitant use with amoxicillin does not affect plasma concentrations of oseltamivir and its components, showing little competition for excretion by anionic tubular secretion. Concomitant administration with paracetamol has no effect on plasma concentrations of oseltamivir and its active metabolite or paracetamol.

Pharmacokinetic interactions between oseltamivir, its main metabolite were not found when concomitantly taken with paracetamol, acetylsalicylic acid, cimetidine or antacids (magnesium and aluminum hydroxide, calcium carbonate), warfarin, rimantadine or amantadine.

. When using Osaltemivir with commonly used drugs such as angiotensin-converting enzyme inhibitors (enalapril, captopril), thiazide diuretics (bendroflumethiazide), antibiotics (penicillin, cephalosporins, azithromycin, erythromycin and doxycycline), H2-histamine receptor blockers (ranitidine, cimetidine), beta-adrenoblockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), glucocorticosteroids, inhaled bronchodilators and non-narcotic analgesics (acetylsalicylic acid, ibuprofen and paracetamol), no changes in the nature or frequency of adverse events were observed.

The use of oseltamivir in combination with drugs with a narrow therapeutic scope (e.g., chlorpropamide, methotrexate, butadione) should be used with caution.

Special Instructions

Extemporaneous preparation of Nomides® suspension from capsules

. In cases where adults, adolescents and children have trouble swallowing the capsules or where there are signs of “aging” of the capsules, you should open the capsule and pour its contents into a small amount (maximum 1 teaspoon) of a suitable sweetened food (chocolate syrup with normal or no sugar content honey, light brown sugar or table sugar dissolved in water, sweet dessert, condensed milk with sugar, apple puree or yogurt) to mask the bitter taste. The mixture should be thoroughly mixed and given to the patient whole. The mixture should be swallowed immediately after preparation.

Capsules 75 mg

If patients require a dose of 75 mg, the following instructions should be followed:

1. Holding one 75 mg capsule of Nomides® over a small container, gently open the capsule and pour the powder into the container.

2. Add a small amount (no more than 1 teaspoon) of a suitable sweetened food (to mask the bitter taste) and mix well.

3. Stir the mixture thoroughly and drink it immediately after preparation. If a small amount of mixture remains in the container, you should rinse the container with a small amount of water and drink the remaining mixture.

If patients require doses of 30-60 mg, the following instructions should be followed for proper dosing:

1. Holding one 75 mg capsule of Nomides® over a small container, gently open the capsule and pour the powder into the container.

2. add 5 ml of water to the powder, using a syringe marked with the amount of liquid taken. Stir thoroughly for 2 minutes.

3. Draw the desired amount of mixture from the container into the syringe according to the following table.

Body weight

Recommended dose

/p>

30 mg

2 ml

>15-23 kg

45 mg

3 mL

>23-40 kg

60 mg

4 ml

There is no need to take the undissolved white powder because it is an inactive filler. Pressing the syringe plunger, inject all of its contents into the second reservoir. The unused mixture must be discarded.

4. Add a small amount (max 1 teaspoon) of a suitable sweetened food item to the second cup, to mask the bitter taste, and mix well.

5. Stir the mixture thoroughly and drink it immediately after preparation. If there is a small amount of mixture left in the container, you should rinse the container with a little water and drink the remaining mixture.

This process needs to be repeated before each dose.

Contraindications

Overdose

Similarities